FiveQ: A new easy‐to‐use validated clinical instrument for tinnitus severity

Abstract Objectives Tinnitus is a complex and debilitating phenomenon with potentially significant implications on quality of life. New presentations can be resource and time intensive for clinicians. Validated comprehensive tinnitus questionnaires may lack practical utility in the high‐volume clinical setting. Concise, targeted questionnaires may offer an efficient alternative. This study aimed to assess the validity of the FiveQ, a novel five question construct designed to measure tinnitus severity. Convergent validity was assessed through correlating FiveQ against two comprehensive validated questionnaires, the Tinnitus Handicap Questionnaire (THQ) and Tinnitus Handicap Inventory (THI). Design Cross‐sectional study with prospective recruitment. The 117 voluntarily recruited participants completed the FiveQ, THI and THQ questionnaires. Results were comparatively analysed. Setting Recruitment was via electronic and print media, audiology clinics and public and private otolaryngology outpatient clinics. Surveys were completed electronically. Participants Members of the public aged over 18 with subjective tinnitus were invited to participate. Main Outcome Measured Analyses for establishing the content validity, construct validity, internal consistency, explorary factor analysis, and responsiveness of FiveQ was performed. Results FiveQ demonstrated a high positive correlation with both the THI (r = 0.773, p < .001) and THQ (r = 0.808, p < .001). Internal consistency for FiveQ reached an acceptable threshold (Cronbach's alpha 0.86). Exploratory factor analysis demonstrated that one latent factor underlies the five items of the FiveQ. FiveQ demonstrated better responsiveness than both the THI and THQ after a 6 week interval repeat measurement. Conclusion FiveQ demonstrated high‐positive correlations with existing validated tinnitus questionnaires as well as acceptable internal consistency and factor analysis. The concise construct of FiveQ allows clinicians to efficiently estimate tinnitus severity, target treatment towards dominant symptoms and establish a reliable estimation of treatment response following interventions.

severity, target treatment towards dominant symptoms and establish a reliable estimation of treatment response following interventions.

K E Y W O R D S
audiology, general, neuro-otology, tinnitus, quality of life 1 | INTRODUCTION

| Background and rationale
Tinnitus is the subjective perception of sound in the absence of auditory stimuli. 1 It represents a complex and debilitating phenomenon that affects one third of individuals throughout their lifetime. 2 Over 20% of tinnitus sufferers report a severe impairment in quality of life (QOL) as a result of their tinnitus. 3 Common severe impairments include sleep disturbance, depression, reduced work productivity, social withdrawal or isolation, and hearing loss. 4 New presentations of tinnitus can be resource and time intensive due to diverse differential aetiologies and wide spectrum of symptomatology. A typical primary care encounter would involve a detailed history, clinical examination, audiogram, investigations, treatment initiation, referral, education and counselling. Associated mood and sleep symptoms invariably necessitate clinicians to diverge into more comprehensive evaluations with an associated impact on consultation time. Establishing an efficient and rapid clinical tool to assess tinnitus severity is fundamental in this setting. 5 With a range of emerging treatments and no current gold standard, 6 there is a need for an efficient, digitalised QOL instrument that provides an accurate measurement of severity and is sensitive to treatment related changes. 7 Established comprehensive questionnaires with multilingual validation, such as the Tinnitus Handicap Questionnaire (THQ), 8 Tinnitus Handicap Inventory (THI) 9 and Tinnitus Functional Index (TFI), 10 play an important role in the accurate assessment of tinnitus. Of those three, only TFI is validated for both initial assessment and clinical surveillance. However, the length of these instruments may lack practical application in high-volume clinical landscapes. Furthermore, tinnitus can fluctuate over time necessitating multiple clinical encounters. The appetite for completing serial time intensive questionnaires may be tempered for patient and clinician.
There is evidence that shorter questionnaires achieve greater compliance, both in the hospital and primary care settings. 11 Within otolaryngology, there is already a trend towards reducing number of questions in QOL instruments such as the Glasgow Benefit Inventory (GBI), with evidence shorter questionnaire can be used without compromising efficacy. 12

| Objectives
Establishing shorter, targeted questionnaires that provide a rapid estimation of tinnitus severity and identify key domains of impairment may offer practical benefits for primary and secondary care clinicians.
We set out to determine whether a novel 5-question questionnaire, FiveQ, demonstrated acceptable correlation with validated comprehensive questionnaires, THI and THQ. Our hypothesis was that individuals who score highly on FiveQ would also score highly on longer-format instruments.

| Ethics statement
Ethics approval was obtained from the Central Adelaide Local Health Network Human Research Ethics Committee(Approval ID 12796). STROBE reporting guidelines were utilised in the preparation of this research.

| Participants
Inclusion criteria were patients aged over 18  • For shorter questionnaires to be effectively integrated into the clinical setting, they must have a concise clinical focus and demonstrate acceptable statistical validity.
• FiveQ is a novel five question construct that focuses on patients' core tinnitus symptoms: sleep, mood, hearing, concentration and activities of daily living.
• FiveQ demonstrated acceptable internal validity, factor analysis and high-positive correlations with longer validated tinnitus quality of life questionnaires.
• FiveQ is a useful tool that clinicians can adopt as a validated and concise assessment of tinnitus severity, allowing targeted treatment towards the dominant symptom, as well as providing a quick and reliable estimate of treatment response. electronic and print media, non-for-profit tinnitus networks, audiology clinics and hospital otolaryngology departments. Each participant was provided with long-term subscription to the sound therapy app used in this study as gratitude for their participation.

| Study design
This was a cross-sectional study with prospective consecutive patient recruitment. Each participant completed all three questionnaires consecutively in the same sitting to assess the convergent validity of FiveQ with validated instruments at baseline. Participants were invited to repeat questionnaires after 6 weeks of sound-based tinnitus intervention to assess the temporal role and responsiveness of FiveQ to changes in symptoms.

| Setting
All questionnaires were completed electronically via the web-based platform SurveyMonkey (SurveyMonkey Inc, San Mateo) and the sound-based tinnitus intervention app.

| Validated comparator questionnaires
The THQ is a multilingual validated tinnitus QOL instrument containing 27 questions separated into three factors: Factor 1-social, emotional and behavioural; factor 2-tinnitus and hearing; and factor 3-outlook on tinnitus. Participants self-report a score from 0 to 100 for each question. Following adjustment for negative questions and weighting, a final score out of 100 is calculated.

| The FiveQ final construct
The five questions examine core tinnitus symptoms of sleep, mood, hearing, concentration and activities of daily living( Figure 1). Patients self-report a score out of 10 for each question(1 indicates no impact, 10 represents intense impact). A score out of 50 is multiplied by two to obtain a score out of 100. Grading out of 100 allows for intuitive interpretation by patients and clinician, ease of comparison with similarly graded questionnaires and ease of classification of symptom severity. Similar to comparator questionnaires, bands are in 20% increments, titled slight, mild, moderate, severe and catastrophic.
Because tinnitus fluctuates with time, questions are time-specific, explicitly focusing on the preceding week.

| Statistical analysis and outcomes measured
Statistical analyses were performed using R (R Foundation for Statistical Computing, Vienna, Austria) through the Jupyter notebook interface. Detailed statistical methodology is included in supplementary 1. Convergent validity was calculated using Pearson's correlation The FiveQ questionnaire contains five questions relating to the key tinnitus symptom domains. Self-reported symptom severity (over the preceding week) is graded from 1 to 10 where 1 represents no impact and 10 represents a profound or intense impact. A final score is tallied and can be converted to a percentage by (total score) Â 2 coefficient(r). Interpretation of the strength of correlations used the terminology by Hinkel. 14 Cronbach's alpha and McDonald's gamma were calculated to assess internal consistency. The acceptable lower limit for an acceptable Cronbach's alpha was taken at 0.7. 15 Exploratory factor analysis(EFA) was performed to assess the latent variables or factors underlying the FiveQ's variables. Responsiveness was assessed through measuring the standardised response mean (SRM) across a 6-week interval, with participants receiving a soundbased tinnitus intervention in the interim.

| Questionnaire outcomes
Each Questionnaire had a final numeric score of 0-100. The mean scores at baseline (n = 117) for all participants were 44.8 (SD = 21.7) T A B L E 1 Tinnitus severity grading from slight to catastrophic using the THQ grading system. THQ and FiveQ scores out of 100 categorised using the same formula

| Internal consistency
The correlation matrix (Pearson's correlation coefficient) between the five variables of FiveQ is presented in Table 2

| Factor analysis
We analysed whether our data was suitable for factor analysis. The   responsiveness of THQ and THI questionnaires as trivial and small, respectively. Our results suggest FiveQ is potentially more responsive than both THQ and THI (Table 3).

| Main outcomes
We introduced a new 5-question clinical instrument for assessing tinnitus severity, and we demonstrated that it has adequate internal consistency, is predominantly unidimensional on factor analysis, and has a high-positive correlation with validated tinnitus questionnaires.

| Validated questionnaire outcomes
A high-positive correlation was observed between THI and THQ (r = 0.860, p < .001). These findings support their ongoing important role in tinnitus management, particularly in the research setting.
However, their lengthy construct may render them impractical in the high-volume setting.

| FiveQ outcomes
Despite being significantly shorter, the FiveQ demonstrated highpositive correlations with both validated questionnaires (r = 0.773 with THI and r = 0.808 with THQ) and the distribution of their scores were not dissimilar, as tested by the Kolmogorov-Smirnov test. These findings support FiveQ as a sound estimation of tinnitus severity, but in a more succinct and time-efficient format. Scoring is designed to be simplistic for easy interpretation for patient and clinician. Focusing on core symptoms also allows patients and clinicians to isolate areas of symptomatic change and hone management accordingly. This efficient and focused design can be integrated into the workflow of a busy clinic, to rapidly screen for symptoms and severity, in settings where more comprehensive questionnaires may prove unwieldy.

| Responsiveness and longitudinal symptom follow-up
FiveQ is designed to be time-specific, with users asked to focus on their symptoms within the preceding week. This enables it to be used in symptom follow up. For an instrument to be used as such, it needs to demonstrate an acceptable level of 'Responsiveness'.
Responsiveness has been defined as the ability of the instrument to detect change in the construct being measured. All 117 participants were invited to repeat the questionnaires after 6 weeks of soundbased tinnitus intervention (described in Methods, and one of the original motivations for developing the FiveQ). The 54 participants completed all follow up questionnaires. The outcomes in this subgroup showed the highest correlation coefficient was between the longer format questionnaires(THI and THQ), however FiveQ also maintained high-positive correlations with THI and THQ. We assessed the responsiveness of FiveQ (through measuring SRM) and found it to display large responsiveness, when compared to THI and THQ, suggesting that it may be a superior instrument for longitudinal symptom follow-up.

| Long versus short questionnaires
Designing optimal questionnaires is challenging and the verdict on long versus short constructs remains an area of scientific investigation. A meta-analysis of questionnaires assessing the association of length and response rate found that longer questionnaires had a trend towards a lower overall response rate. 11 Longer questionnaires provide a more thorough analysis but may compromise on power through low compliance and participation. Where shorter questionnaires correlate strongly with longer questionnaires, the shorter construct may be preferable. 17